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Completed

NCT Number: NCT01107093

Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge

Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered after the onset of the LH surge on the outcome of the leading ovary follicle:

* echographic follicle rupture * inhibition of follicle rupture * luteal phase progesterone levels * anovulatory progesterone levels

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

ICMER, Santiago, Chile

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women of good general health aged 18 - 35 years
  • Not at risk of pregnancy
  • Regular menstrual cycles of 24-35 days duration
  • Not pregnant
  • Intact uterus and ovaries
  • Haemoglobin ≥ 11 g/dl
  • Normal laboratory tests and normal TSH
  • Willing to abstain from any use of hormonal contraception until study completion
  • No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since termination of previous hormonal contraception
  • Had at least one complete menstrual cycle (2 menses) following delivery, miscarriage or induced abortion
  • Able to give voluntary, written informed consent, and agreeing to observe all study requirements for 5 complete menstrual cycles

Exclusion criteria

  • Current participation in any other trial of an investigational medicine
  • Known hypersensitivity to the ingredients of the test active substances or excipients
  • Suspected hyperplasia or carcinoma of the endometrium
  • Current pregnancy as confirmed by positive serum beta-hCG at screening
  • Desire to get pregnant before the planned end of the study participation
  • Currently breastfeeding
  • Abnormal Pap smear
  • Cancer (past history of any carcinoma or sarcoma)
  • Known or suspected alcoholism or drug abuse
  • Abnormal thyroid status
  • Body mass index > 32
  • Current use of hormonal contraception
  • Use of hormonal emergency contraception since last menstrual period
  • Severe asthma insufficiently controlled by oral glucocorticoids
  • Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

Treatment and study plan

CDB-2914 (ulipristal acetate)

Drug

single oral dose of 30 mg

Placebo

Drug

single oral dose

Primary outcomes

  1. Inhibition of follicular rupture

    Time frame: within 6 days after treatment intake

    Inhibition is calculated as the number of subjects exhibiting no dominant follicle rupture, divided by the total number of subjects having received treatment

Secondary outcomes

  1. Appearance or absence of a corpus luteum

    Time frame: during the 6 days following treatment intake

  2. Growth pattern of leading follicle

    number of cycles exhibiting atresia (diameter decrease ≥25%), or continued growth (diameter increase ≥25%), or interrupted growth (size remains within ±25% of the follicle size at the time of treatment)

  3. Presence or absence of a surge of serum luteinizing hormone (LH) levels

    The onset of an LH surge is defined as the occurrence of the first single serum LH value whose level is at least 50% higher than the mean of the last two previous measurements, or higher than the last previous measurement if only one previous LH level is available.

  4. Menstrual cycle length in comparison to the subject's reported baseline average cycle length and to her placebo-treated cycle length

  5. Incidence of intermenstrual bleeding and treatment-emergent adverse events

  6. Incidence of adverse events and occurrence of abnormal laboratory safety variables in comparison with baseline

  7. Incidence of ovarian cysts after CDB-2914 treatment

Sponsors and collaborators

Lead sponsor

HRA Pharma

Industry

Registry information

Official study title

A Prospective, Randomized, Double-blind, Cross-Over Study to Compare the Capacity to Prevent Follicular Rupture of CDB-2914 With Placebo, When Administered After the Ovulatory Process Has Been Triggered by the LH Surge

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 20, 2010
Registry last updated
Aug 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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